job description

The purpose of this position is to: Plan, initiate and execute assigned clinical studies with operational excellence.

Be accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality

Be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies The scope of this position is Phase 1 through 4 APGD-sponsored clinical studies.

Position Responsibilities

Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Manage and lead cross-functional study teams, including vendors.

Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.

Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.

Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data.

Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.

Lead feasibility assessment and selection of countries and sites for study conduct.

Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.

Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.

Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies.

Responsible for study budgets up to $100M.

Position Requirements

BA/BS degree with at least five years multi-country clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience.

Must have strong knowledge of ICH/GCP guidelines.

Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.